Immuron plans Phase 2 trial for IMM-529 following FDA review Page 1

Important points

• Immuron completes pre-IND meeting with FDA to develop IMM-529 as a product for specific prevention or treatment Clostridioides difficile
  Infection (CDI)
• Data from previous clinical studies of IMM-529 support the further development of IMM-529
• Investigational New Drug (IND) Application for IMM-529 planned for 1H 2025

MELBOURNE, Australia, Sept. 5, 2024 (GLOBE NEWSWIRE) — Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian-based and globally integrated biopharmaceutical company, is pleased to announce that it has received positive feedback from the U.S. Food and Drug Administration (FDA) on the Pre-IND (Investigational New Drug) information package to support the clinical development of IMM-529.

Following FDA guidance and feedback, the company now plans to submit an Investigational New Drug (IND) application for IMM-529 to Clostridioides difficile Infection (CDI) in the first half of 2025, followed by a Phase 2 study with IMM-529 in people with Clostridioides difficile Infection.

The increasing incidence of antibiotic-resistant ‘superbugs’ has increased the use of broad-spectrum antibiotics worldwide. An unintended consequence of antimicrobial treatment is the disruption of the gastrointestinal microbiota, leading to susceptibility to opportunistic pathogens, such as Clostridioides difficile (C. diff). Paradoxically, the treatment of Clostridioides difficile Infection (CDI) is also associated with antibiotic use, and the heavy reliance on antibiotics to control C. diff. does not allow for regeneration of the gut flora and leaves the patient vulnerable to relapse of CDI. C. diff. is currently the most common pathogen in healthcare-emergent infections and was identified as an urgent threat in the Center for Disease Control and Prevention report on the Threat of Antibiotic Resistance in the United States (CDC, 2019). CDI affects over 400,000 people annually in the United States and contributes to over 30,000 deaths annually in the United States alone. This serious health threat has led to an urgent call for the development of new therapeutics to reduce or replace the use of antibiotics to treat bacterial infections.